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Generated: December 14, 2017

DrugPatentWatch Database Preview

Lenalidomide - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of lenalidomide patent protection?

Lenalidomide
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has four hundred and ninety-four patent family members in forty-five countries and seventeen supplementary protection certificates in twelve countries.

There are twelve drug master file entries for lenalidomide. One supplier is listed for this compound.

Pharmacology for lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-006Jun 5, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-005Dec 21, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-002Dec 27, 2005RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-001Dec 27, 2005RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-002Dec 27, 2005RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-005Dec 21, 2011► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lenalidomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,673,939Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione► Subscribe
8,623,384Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of acute myelogenous leukemia► Subscribe
7,459,466Substituted 2-(2,6-dioxopiperidin-3-yl)-phthalimides and -1-oxoisoindolines and method of reducing TNF.alpha. levels► Subscribe
8,188,118Method for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with antibodies► Subscribe
8,722,705Methods for treating diffuse large B-cell lymphoma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents► Subscribe
7,959,566Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
6,869,399 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
8,440,194Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
9,662,321Methods for treating newly diagnosed multiple myeloma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents► Subscribe
9,498,472Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: lenalidomide

Country Document Number Estimated Expiration
Australia780486► Subscribe
New Zealand584663► Subscribe
Spain2402808► Subscribe
Japan5839770► Subscribe
Israel174067► Subscribe
Taiwan200730175► Subscribe
Japan2013049734► Subscribe
Eurasian Patent Organization200600535► Subscribe
European Patent Office2460522► Subscribe
China104059052► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LENALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0150005 00140Estonia► SubscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
2015Austria► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2 50002-2015Slovakia► SubscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
C0056France► SubscribePRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070614
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
90004-6Sweden► SubscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
0717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
C/GB07/047United Kingdom► SubscribePRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
56/2007Austria► SubscribePRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cipla
Citi
AstraZeneca
Healthtrust
Express Scripts
Baxter
Cerilliant
Fuji
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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